CN101677749A - Be used to remove biomembranous surgical instruments, system and method - Google Patents

Be used to remove biomembranous surgical instruments, system and method Download PDF

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Publication number
CN101677749A
CN101677749A CN200880013653A CN200880013653A CN101677749A CN 101677749 A CN101677749 A CN 101677749A CN 200880013653 A CN200880013653 A CN 200880013653A CN 200880013653 A CN200880013653 A CN 200880013653A CN 101677749 A CN101677749 A CN 101677749A
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nozzle
introducer
target site
distal portions
respect
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CN101677749B (en
Inventor
D·E·斯兰科尔
J·R·普力斯科
C·O·莱威斯
G·W·诺曼
R·K·瓦卡洛
I·C·佩里
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Medtronic Xomed LLC
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Medtronic Xomed LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005Flexible endoscopes
    • A61B1/0051Flexible endoscopes with controlled bending of insertion part
    • A61B1/0055Constructional details of insertion parts, e.g. vertebral elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3203Fluid jet cutting instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015Control of fluid supply or evacuation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/227Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes
    • A61B1/2275Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes with controlled air pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/233Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the nose, i.e. nasoscopes, e.g. testing of patency of Eustachian tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71Suction drainage systems
    • A61M1/77Suction-irrigation systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0147Tip steering devices with movable mechanical means, e.g. pull wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0233Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0258Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • A61B2017/00305Constructional details of the flexible means
    • A61B2017/00314Separate linked members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/24Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A61B2017/242Surgical instruments, devices or methods, e.g. tourniquets for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers for bronchial passages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/007Auxiliary appliance with irrigation system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0618Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0202Enemata; Irrigators with electronic control means or interfaces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0208Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022Volume; Flow rate

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pathology (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Otolaryngology (AREA)
  • Mechanical Engineering (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Be used for removing from the target site of human patients the system and method for bacterial biof iotalm, comprise surgical instruments, this apparatus has the introducer that is used for the health insertion and keeps irrigating catheter and nozzle.The distal portions of this introducer is convertible with respect to its proximal part between a plurality of angle of bend.Particularly, this apparatus is suitable for independently distal portions being remained on respect to proximal part each angle place of a plurality of angle of bend.This nozzle keeps with respect to the distal portions of introducer, and is suitable for from the irrigation of irrigating catheter to bacterium living beings rete dispense pressurised.

Description

Be used to remove biomembranous surgical instruments, system and method
Technical field
Bacterial biof iotalm appears in the various body cavitys, for example, comprises such as the ear chamber of middle ear with such as the nasal cavity of preceding hole or maxillary sinus.In case bacterial growth forms, this antibacterial assembles usually, stop to disperse, and begin to form the protectiveness bacterium living beings rete that constitutes by polysaccharide matrix, or " rete malpighii ".
Background technology
The protectiveness bacterial biof iotalm disturbs the natural immunity of human body to reply and traditional Therapeutic Method.Particularly, antibacterial produces extracellular toxin, and extracellular toxin stimulates the immune system of human body to reply with leukocyte.Yet bacterial biof iotalm is disturbed the effectiveness of leukocyte attack bacteria ability.Biomembrane also serves as the barrier of the local application of opposing antibiotic and other medicines.Forming biomembranous antibacterial also becomes killing the obstacle of traditional antibiotic therapy of working of division antibacterial.Particularly, the antibacterial that is in biomembrane formation state may stop cell division, makes this antibiotic inoperative to a great extent.
For example, for chronic sinusitis and other similar disease, the antibacterial in nose can be regarded continuum (continuum) as.Some antibacterials (for example, some bacterial strain of Rhodopseudomonas and gold-coloured staphylococci) form firm biomembrane.Other (for example, hemophilus influenzas (h.flu)) form gentle relatively biomembrane.Biomembrane may or may not comprise or comprise fungus.These microorganisms have slightly different or complementary inflammatory approach for every kind, and differently interact with host's immune system.For example, gold-coloured staphylococci produces and serves as antigen and cause the lipopolysaccharide substrate that the host replys, and toxin (for example, staphylococcus exotoxin A and B, toxic shock syndrome toxin 1 and 2), these toxin can produce that antigen is replied and even high antigen superantigen (high inflammation) reply.Recent document proposition chronic sinusitis is the inflammatory reaction to bacterial biof iotalm.Other microorganism also can produce the inflammatory stimulus toxin.Anchorage of basis antibacterial and biomembranous intractable make them be difficult to treatment.
Functional endoscopic operation on nasal sinus (FESS) is the surgical operation of minimum invasion and attack that is used for the treatment of chronic sinusitis and treats other infection of nasal sinuses possibly.FESS utilizes the apparatus that helps by endoscope to open hole air chamber and Dou Kou (opening).As the hole surgical method, the use of FESS is accepted now widely.The purpose of FESS is normally recovered the normal drain of hole and is made their ventilations.But FESS can not solve the problem of bacterial biof iotalm recited above.
Though ventilation operation can make some biomembranes be removed once in a while, remain many biomembranes after the operation, and with needs further treatment be prerequisite, to remove bacterial biof iotalm at paranasal sinuses and other body part.
Summary of the invention
Some embodiment relate to bacterial biof iotalm and remove system, and this system comprises the apparatus that is used for removing from target site bacterial biof iotalm.This apparatus comprises the introducer that is used for the health insertion.This introducer comprises proximal part and distal portions again.This distal portions is convertible between a plurality of angle of bend with respect to proximal part.Particularly, this apparatus is suitable for independently distal portions being remained on respect to proximal part each angle place of a plurality of angle of bend.This apparatus also comprises and is used to carry the irrigating catheter of irrigation and the nozzle that is communicated with this irrigating catheter fluid.This nozzle is held with respect to the distal portions of introducer, and is suitable for from the fluid of irrigating catheter to bacterium living beings rete dispense pressurised, to clean bacterial biof iotalm from target site.In certain embodiments, nozzle rotatably keeps by introducer.In other embodiments, this system also comprises optional endoscopic system, and this endoscopic system comprises the endoscope that is used to make the target site imaging.
Other embodiment relates to the method for removing bacterial biof iotalm from the target site of human patients.Provide a kind of bacterial biof iotalm to remove system, this system comprises surgical instruments.This apparatus has the introducer of the nozzle that keeps irrigating catheter and be communicated with this irrigating catheter fluid.This nozzle is positioned at the far-end of introducer, and wherein the distal portions of introducer flexibly connects with respect to its proximal part.The distal portions of introducer is performed the operation to be inserted in patient's body.Nozzle is sent near target site, and wherein target site comprises the bacterium living beings rete that is adhered to the surface.The irrigant stream of pressurization is distributed to target site by nozzle, mechanically to destroy or to remove most bacterium living beings rete from this surface.In certain embodiments, adopt endoscope, to help locating nozzle with respect to target site.
Description of drawings
Figure 1A is a sketch map of removing system according to the surgery biological film of disclosure principle;
Figure 1B is a sketch map of removing system according to the another kind of surgery biological film of disclosure principle;
Fig. 2 is the side perspective view of the surgical instruments used of the system with Figure 1A and 1B;
Fig. 3 is the guide wire of alternative shape (some parts is removed) of Fig. 2 apparatus;
Fig. 4 is the perspective view of the connector part of Fig. 2 apparatus;
Fig. 5 is the decomposition diagram that the connector assembly of Fig. 4 is shown;
The perspective view of Fig. 6 two optional connectors that to be final assembling back use with the apparatus of Fig. 2;
Fig. 7 is the enlarged perspective of distal portions of the introducer of Fig. 2 apparatus;
Fig. 8 is the vertical view of Fig. 2 apparatus;
Fig. 9 is the perspective view of Fig. 2 apparatus, and the flexible connection of its introducer part is shown;
Figure 10 removes the perspective view of apparatus according to disclosure principle and with the another kind of surgery biological film that the system of Figure 1A and 1B uses;
Figure 11 is the zoomed-in view (wherein a part is removed) of the surgical instruments of Figure 10;
Figure 12 A is the viewgraph of cross-section along the introducer part of Figure 11 apparatus of line 12A-12A intercepting;
Figure 12 B is the viewgraph of cross-section along the introducer part of Figure 11 apparatus of line 12B-12B intercepting;
Figure 13 A is the enlarged perspective of introducer intermediate connector of the apparatus of Figure 11;
Figure 13 B is the enlarged perspective of introducer near-end connector of the apparatus of Figure 11;
Figure 14 is the enlarged perspective of introducer of the apparatus of Figure 10;
Figure 15 is the vertical view of the apparatus of Figure 10;
Figure 16 illustrates the method for removing the bacterial biof iotalm relevant with human anatomy according to principle of the present disclosure;
Figure 17 and 18 illustrates according to the surgery biological film of some other embodiment and removes apparatus;
Figure 19 and 20 illustrates according to the surgery biological film of other other embodiment and removes apparatus; And
Figure 21 and 22 illustrates the basis surgery biological film removal apparatus of other embodiment more again.
Specific embodiment
The each side of embodiment described here relates to one or more system, the method and apparatus that is used to reduce, remove bacterial biof iotalm or stops the bacterial biof iotalm growth.Particularly, will be understood that surgery biological film removal system, the method and apparatus that is suitable for use in this purposes with reference to context and accompanying drawing.
Figure 1A illustrates according to the surgery biological film of some embodiment and removes system 20.This system 20 comprises biomembrane removal surgical instruments 22, fluid source 24, vacuum source 26 (total labelling) and controller 28.Generally speaking, fluid source 24 for example provides fluid or irrigation via fluid connector 30 (for example, pipeline) for apparatus 22.On the contrary, vacuum source 26 for example provides vacuum-flow or suction streams via vacuum coupling 32 (for example, pipeline) for apparatus 22.The operating aspect of these systems 20 of controller 28 control, and be expressed as usually and be associated with apparatus 22 and fluid source 26.System 20 can comprise additional parts.For example, the another kind of surgery biological film that is shown in Figure 1B is removed system 20 ' and is comprised the identical parts with system 20 (Figure 1A), and optional endoscopic system, and it comprises endoscope 34 and such as the associated components of light source 36 and imaging device 38.In general, endoscope 34 can have conventional structure, and wherein light source 36 and imaging device 38 are convenient to the visual, as described below of biomembrane removal surgical instruments 22 confined surgical areas in one's power.But, in other embodiments, can be provided with separately or divide be arranged endoscope 34 and associated components 36,38, and/or they are saved (for example, the system 20 of Figure 1A) with system 20 '.
As following described in more detail, biomembrane is removed surgical instruments 22 can take various forms.But generally speaking, apparatus 22 comprises handle 40 and introducer 42.This introducer 42 extends from handle 40, and size is made and is used for inserting patient's body with minimum mode of invasion surgery.Introducer 42 remains on its far-end with nozzle 44 (total labelling), and keeps setting up between nozzle 44 and fluid connector 30 in addition the irrigating catheter (being hidden among Figure 1A and the 1B) that fluid connects.Suction catheter (being hidden among Figure 1A and the 1B) also can be kept by introducer 42., as opinion how for the locus of the nozzle 44 that obtains to expect, and in order to obtain near the intravital specific part of body, at least a portion of introducer 42 flexibly connects, and is as described below.And handle 40 keeps comprising the triggering assembly 45 of actuator 46.When pressing hydraulic actuator 46, signal is fed to controller 28 via adapter 47, carries irrigation to impel to apparatus 22.
Consider the above-mentioned general structure of apparatus 22, a kind of acceptable structure that the surgery biological film is removed apparatus 48 is shown in Fig. 2.This apparatus 48 comprises handle 50, introducer 52, nozzle 54 and flushing and suction catheter (not shown).Apparatus 48 can also randomly comprise first actuator 56 (total labelling) and second actuator 58 (total labelling).The details of each parts is provided below.But generally speaking, handle 50 keeps introducer 52, and introducer 52 is transported to the surgery target site with being suitable for minimum invasion and attack in addition.In this respect, introducer 52 remains on its far-end with nozzle 54, and carries the irrigant stream (not shown) of pressurization by it, removes operation to carry out biomembrane.Consider this point, first actuator 56 is operated by user, to realize the bending (for example, entering or leave the view plane of Fig. 2) of introducer 52.Second actuator 58 is operated by user, moves with respect to introducer 52 or rotates to realize nozzle 54.
Handle 50 can be taked various forms, and is used as the housing of the various parts of apparatus 48 usually, and keeps introducer 52.In certain embodiments, handle 50 has the shape of pistol grip shape, and it has defined the shank portion 60 and the mouth of pipe (nose) 62.The size and dimension of this shank portion 60 is made the grasped by user, and the mouth of pipe 62 is suitable for being connected to introducer 52.Alternatively, other structure also is acceptable (other shape or the size of the pistol grip shape design shown in for example, handle 50 can be taked to be different from).
With reference to figure 3, handle 50 has defined the inside 64 that holds various parts.For example, handle 50 can keep flushing pipe 66 and suction extraction channel runs 68.This flushing pipe 66 and suction extraction channel runs 68 are extended and the sensing mouth of pipe 62 from the tail end 70 of handle 50, therefore point to introducer 52.In this respect, flushing pipe 66 can be set to the continuity of the fluid connector 30 shown in Figure 1A, and the continuity that suction extraction channel runs 68 can be used as to the vacuum coupling 32 of Figure 1A is provided with.Alternatively, handle 50 can comprise respectively at the suitable port organization that provides fluid to connect between flushing pipe 66 and the fluid connector 30 and between suction extraction channel runs 68 and vacuum coupling 32.In any case flushing pipe 66 is used for flush fluid from fluid source 24 (Figure 1A) guiding introducer 52, and the fluid that suction extraction channel runs 68 is used for being sucked is from introducer 52 guiding vacuum sources 26 (Figure 1A).
In certain embodiments, as described below, flushing pipe 66 terminates in assembly parts 72 places that are provided with as the part of second actuator 58.In this respect, flushing carrier pipe 74 extends from the opposite side of assembly parts 72, and wherein these assembly parts 72 are set up the fluid connection between flushing pipe 66 and flushing carrier pipe 74.Because this structure is so flushing carrier pipe 74 extends in the introducer 52 and passes through introducer 52, and fluid is connected in nozzle 54 (Fig. 2).Flushing pipe 66, assembly parts 72 and flushing carrier pipe 74 form irrigating catheter together, and flush fluid is transported to nozzle 54 by this irrigating catheter from fluid source 24 (Figure 1A), removes the part of operation as biomembrane.Alternatively, various other structures of irrigating catheter are acceptable equally.For example, irrigating catheter can be the monolithic entity (for example, irrigating catheter 66) that directly extends through handle 50 and introducer 52.
Suction extraction channel runs 68 is shown among Fig. 3, and it extends through handle 50 and introducer 52, and forms suction catheter, can be from aspirated at fluid and other material of introducer 52 far-ends by this suction catheter.But, alternatively, one or more additional tubular parts can also be set, to form suction catheter.
Except pipeline 66,68, handle 50 also keeps triggering assembly 80, and in certain embodiments, this triggering assembly 80 comprises actuated piece 82, pick off 84 (roughly drawing) and adapter 86.This actuated piece 82 extends from shank portion 60 outsides and is suitable for being activated by the user (not shown), for example, activates with respect to shank portion 60 via sliding interface.In this respect, trigger assembly 80 and can also comprise and be used for actuated piece 82 is biased to other parts (not shown) of extended position (with respect to shank portion 60), as shown in Figure 3.The actuating of actuated piece 82 is inevitable, and it is enough to overcome the power of bias unit with the thrust that is applied thereto, therefore slide actuated part 82 inwards; Alternatively, other actuating structure also is an acceptable.Pick off 84 is suitable for providing the output of the actuating (for example slide and move) of indication actuated piece 82, therefore can take to be suitable for the various forms of the motion of sensing actuated piece 82.Adapter 86 is suitable for again carrying or transmit output from this pick off 84.Therefore, adapter 86 can be taked various forms (for example, pipeline, distribution etc.), and is connected in (wired or wireless) controller 28, shown in the adapter 47 of Figure 1A.For example, adapter 86 is connected in pick off 84 and protruding from handle 50 via tail end 70.
Turn back to Fig. 2, introducer 52 has the common elongated shape of extending from the mouth of pipe 62 of handle 50, and size is made the health insertion that is suitable for minimum invasion and attack.In this respect, as mentioned above, introducer 52 keeps flushing and suction catheter (being hidden among Fig. 2) along its length, and comprises or form proximal part 90 and distal portions 92.This proximal part 90 extends from the mouth of pipe 60, and distal portions 92 extends from proximal part 90, terminates in far-end 94.As described in greater detail below, in certain embodiments, the characteristic of proximal part 90 is inflexible, and distal portions 92 is flexible or flexibly connects, so that far-end 94 can carry out moving of user control with respect to handle 50.In any case nozzle 54 remains on far-end 94 by introducer 52.
Proximal part 90 comprises and is suitable for supporting various internal parts and with respect to the shell 96 of front side 98 support on the neck parts 92.Generally speaking, shell 96 is essentially tubular, forms one or more inner chamber (not shown), intracavity is furnished with various parts (promptly in this, suction extraction channel runs/suction catheter 68 (Fig. 3), flushing carrier pipe/irrigating catheter 74 (Fig. 3), various tinsel (not shown) etc.).In this respect, as mentioned above, flushing and/or suction catheter can be the forms of pipe (one or more) of the independent formation of the inner chamber (one or more) that extends through shell 96; Alternatively, the inner chamber of shell 96 (one or more inner chamber) can be as one of flushing and/or suction catheter (one or more) or both parts.In certain embodiments, shell 96 is formed by quite inflexible, surgical operation safe material (for example, plastics, rustless steel), though other material also is an acceptable.
Compare with proximal part 90, distal portions 92 is flexible, and in certain embodiments, this flexibility is produced by the framework 100 of movable connection.This framework 100 is suitable for supporting the various internal part (not shown) (for example, suction extraction channel runs/suction catheter 68 (Fig. 3), flushing carrier pipe/irrigating catheter 74 (Fig. 3), tinsel etc.) that extend through it, and supports the nozzle 54 that remains on far-end 94.Consider this point, in certain embodiments, framework 100 is made of a plurality of connectors 102.As described below, the contiguous connector of connector 102 is connected to each other rotationally or hingedly in the mode that allows to relatively move.
An acceptable embodiment of connector 102 is shown in further detail among Fig. 4 and (should be appreciated that connector 102 can have same structure).Connector 102 comprises framework 110, first flange 112 and second flange 114.Framework 110 forms first passage 116 and second channel 118, and wherein passage 116,118 longitudinal extensions are by framework 110.The size of first passage 116 is made and is admitted flushing carrier pipe/irrigating catheter 74 (Fig. 3), and the size of second channel 118 is made admittance suction extraction channel runs/suction catheter 68 (Fig. 3).In this respect, though first and second passages 116,118 relative to each other open wide in framework 110, but can form part convex shoulder 120, it is suitable for catching slidably the flushing carrier pipe/irrigating catheter 74 relevant with first passage 116, with the suction extraction channel runs/suction catheter 68 relevant with second channel 118.But alternatively, framework 110 can form single passage (for example, can cancel convex shoulder 120), or passage 116,118 can be relative to each other closed.Even in other embodiments, can form a plurality of passages by framework 110, or a plurality of passage forms in framework 110.
With the number and/or the structure-irrelevant of passage 116,118, framework 110 can also comprise first and second ribs 122,124 in its relative both sides.This rib 122,124 forms to extend radially out part with respect to framework 110 usually, and it is contiguous to be positioned at part convex shoulder 120, so that the whole width of connector 102 is minimized.In any case each rib 122,124 forms or has defined from first side 128 of framework 110 to vertical hole 126 that second side 130 (total labelling) is extended.As shown in Figure 4, rib 122,124 can be configured such that hole 126 is radially unlimited along slit 132.In any case as described below, each size of hole 126 is made and is admitted slidably and the relevant tinsel (not shown) of first actuator 56 (Fig. 2).
First and second flanges 112,114 stretch out from the opposite end of framework 110.For example, with respect to the direction of Fig. 4, first flange 112 stretches out " top " end 134 of this framework 110, and second flange 114 stretches out from " end " of framework 110 end 136 and (is to be understood that, connector 102 also can make term " top " and " end " not be subjected to any restriction along any direction orientation).Consider these routines, each flange 112,114 comprises or forms stiff end 138 and free end 140.This stiff end 138 is connected with the corresponding end 134 or 136 of framework 110, and free end 140 separates (that is, second side 130 away from framework 110 is provided with or arrangement) with framework 110.Each comprises flange 112,114 or forms and be positioned at the horizontal aperture 142 that free end is contiguous, extend through its thickness.And free end 140 forms the curved surface 144 of convex, and stiff end 138 forms the curved surface 146 of corresponding spill.As described in greater detail below, convex and concave surface 144,146 have shape corresponding or coupling, make when connector 102 is assemblied in the second connector (not shown), but the relation of formation translation.At last, connector 102 comprises first pin 148 and second pin 150.This first pin 148 is from top 134 horizontal expansions of framework 110, and 136 horizontal expansions from the bottom of second pin 150.Pin the 148, the 150th in certain embodiments, same structure, and size is made and rotatably is received in the aperture 142 relevant with the corresponding flange 112 of independent one connector 102 or 114.
Consider said structure, Fig. 5 illustrates the example assembled of second connector 102b of first connector 102a of connector and connector with the form of exploded view.As the reference point, for easy explanation, about the key element numbering of the above-mentioned identification of the connector 102 of Fig. 4 in Fig. 5 with " a " or " b " name, corresponding to described connector 102a or 102b.Consider this point, connector 102a, 102b assemble mutually and make the first flange 112a of first connector 102a be assemblied in the top 134b of second connector 102b, and the second flange 114a is assemblied in bottom 136b.More particularly, the first pin 148b of second connector 102b rotatably is received in the aperture 142 of the first flange 112a of the first connector 102a, and the second pin 150b rotatably is received in the aperture 142 of the second flange 114a.In this respect, concave surface 146 couplings of the convex surface 144 of the first flange 112a of the first connector 102a and the first flange 112b of second connector 102b, make the flange 112a that wins to rotate (around the first pin 148b) (promptly with respect to the first flange 112b, the convex surface 144 of the flange 112a of first connector can along or with respect to concave surface 146 translations of the flange 112b of second connector, vice versa).Same relation is also set up between the second flange 114a, 114b.After the assembling, first rib 122a, 122b vertically align, and second rib 124a, 124b are also like this.Because this set, as described below, the tinsel (not shown) can extend through rib 122a, 122b and 124a, the 124b of alignment continuously.Equally, first passage 116a, 116b alignment is used to admit irrigating catheter 74 (Fig. 3). Second channel 118a, 118b alignment is used to admit suction catheter 66 (Fig. 3).
According to principle of the present disclosure, the structure of connector 102 recited above (comprising connector 102a, 102b) is a kind of acceptable structure.For example, Fig. 6 illustrates the optional structure that is used for connector 160 of the present disclosure.Connector 160 (Fig. 6 illustrates two (160a, 160b) wherein) also comprises framework 162 and relative flange 164,166.Each flange 164,166 comprises convex side 168 and concave side 170, wherein convex side 168 is configured to be connected rotationally with the concave side of the flange 164 of the second adjacent connector or 166 (for example, the concave side of the flange 164 of the first connector 160a admit the flange 164 of the second connector 160b convex side).Be provided with differently with the hinge joint of Fig. 5, the connector 160 of Fig. 6 has been introduced the pivoting interface of opening between adjacent connector 160a, 160b.Because this structure, under the situation of the load that raises (for example, attempt relative to each other to rotate significantly or rotate adjacent connector 160a, 160b), what form between the adjacent ribs of flange 164 or 166 pivotally connectedly can crooked leave suitable position, and can return elastically when removing load.
Turn back to Fig. 2, with definite structure-irrelevant, framework 100 is assembled to the front side 98 of proximal part 90, so that form near-end connector 180 and far-end connector 182.The distal portions 92 of user control mobile (or crooked) described in more detail below with reference to first actuator 56 (the total labelling among Fig. 2).In any case far-end connector 182 terminates in far-end 94 or forms far-end 94, and keeps nozzle 54, show as Fig. 7 is clear.In addition, the second channel 118 of far-end connector 182 longitudinally opens wide with respect to introducer 52 outsides, therefore form the suction inlet 184 (not shown or hiding in Fig. 7, as can be the suction channel 68 (Fig. 3) that extends through introducer 52 in addition still) that other fluid is connected in above-mentioned suction catheter.For this reason, suction catheter can distally stretch out by also surpassing far-end connector 182, and wherein the far-end of suction catheter forms suction inlet 184.
Nozzle 54 can be taked various forms, but is configured to produce the jet graphics of fan shape in certain embodiments, and is rotatably kept by far-end connector 182, or is assemblied in far-end connector 182.As the reference point, according to aspects more of the present disclosure, provide biomembrane to remove surgical instruments 22 (Figure 1A), flow mechanically disrupting biofilm to use the fluid that produces by nozzle 54.In this respect,, be surprisingly found out that fan-shaped spray type nozzle is configured in biomembrane removal aspect can provide beyond thought benefit though nozzle 54 can be simple pass nozzle.Hole nozzle produces the conflux that approximates this bore dia greatly.This conflux produces mechanical destruction again to the relatively little area of organizing between the operating period.In order to realize large-area biomembrane removal, so the pass nozzle spatially may must flexibly connect, to handle other zone.But by a kind of structure of Fig. 7, nozzle 54 produces the fan-shaped spray type nozzle of mechanical destruction to tissue " line ".When nozzle 54 around its when rotation axle (as described below), this line then can inswept sizable area of organizing.
Because above-mentioned consideration, nozzle 54 can be the cast body, and its formation is assemblied in the bottom 186 (total labelling) of introducer 52, with relative preceding hemispherical end 188, forms V-notch 190 at this hemispherical end place.In certain embodiments, and as shown in Figure 7, form V-notch 190, extend, so that produce side-looking injection scheme figure (and therefore as described below cover bigger area) by swivel nozzle 54 with a side 192 along nozzle 54.Alternatively, this V-notch 190 can form with respect to the axis centre ground of nozzle 54.As how discussing, have been found that control is the angle of V-notch 190 and the internal diameter of nozzle 54 hole (not shown) by the parameter of the fan-shaped spray figure of nozzle 54 generations.Consider these parameters, be surprisingly found out that, when to supply with flow rate be 6mL/ second when producing jet power and equal can to reach the power that obtains on 1.3 inches distances with 0.03 inch hole nozzle, can realize being suitable for the operative nozzles structure, wherein V-notch 190 be formed in 25 ° of-100 ° of scopes angle and at the 0.0001-0.0007 inch 2Internal diameter opening size in the scope.But alternatively, various other structures that are used for nozzle 54 also are acceptables.In any case nozzle 54 is assemblied on the introducer 52, make the front end 188 of nozzle 54 distally stretch out far-end 94 above introducer 52, therefore not influenced by introducer 52 by V-notch 190 or the jet graphics that produces by V-notch 190.
Be configured to provide the motion or the flexible connection of the distal portions 92 of user control referring to figs. 2 and 3, first actuator 56, and it comprises actuator 200, first tinsel 202 and second tinsel 204 in certain embodiments.As described below, first tinsel 202 and second tinsel 204 are assemblied on the actuator 200, and extend to introducer 52.Utilize this structure, the motion of actuator 200 is transferred on the tinsel 202,204, and this realizes the motion of introducer 52 again, and particularly, distal portions 92 is with respect to the motion of handle 50.
In certain embodiments and specifically with reference to figure 3, actuator 200 comprises wheel 206 and control knob 208.Wheel 206 is rotatably mounted in handle 50, and wherein control knob 208 radially extends from wheel 206, and after final assembling, protruding with respect to handle 50.Utilize this structure,, in other words, for example hold handle 50 by the thumb of user so control knob 208 can be used for being operated by the user (not shown).In any case wheel 206 is rotatable with respect to handle 50 around central point 210, and can comprise or form one or more grooves 212 in certain embodiments.The size of each groove 212 is fit to catch releasedly in addition the control volume (not shown) of the correspondence that is supported by handle 50, so that with respect to handle 50 selectivitys " locking " wheel 206.For example, the ball to wheel 206 biasings can be set, and size is fit to optionally embed in the corresponding groove 212.Alternatively, can adopt various other locking-type mechanisms, make groove 212 can take other form and/or can be cancelled.In further embodiments, first actuator 56 does not comprise locking mechanism.
Each is fixed in wheel 206 dividually first tinsel 202 and second tinsel 204, for example extends in the circumferential groove 214 that is formed by wheel 206 (total labelling).As shown in the figure, tinsel 202,204 each extend from the mouth of pipe 62 of wheel 206 to handle 50.For this reason, apparatus 48 can also comprise the first and second tinsel guides 216,218 that guide this tinsel 202,204 along handle 50 inside respectively, so that avoid undesirable contact of other parts with apparatus 48.In this respect, tinsel guide 216,218 can be supported by one or more walls 220 of installing or be arranged in the handle 50.In any case as described below, tinsel 202,204 extends through the mouth of pipe 62 and enters introducer 52.With respect to the orientation that makes progress of Fig. 2, in certain embodiments, first actuator 56 is configured, and makes tinsel 202,204 from be transformed into horizontal orientation or the horizontal relationship on the mouth of pipe 62/ introducer 52 in the vertically-oriented or vertical relation on the wheel 206.That is to say, with respect to the mounting points of wheel 206, first tinsel 202 second tinsel 204 " above "; On the contrary, when being arranged on the mouth of pipe 62/ introducer 52 places, first and second tinsels 202,204 are alignment flatly usually.But alternatively, other various structures also are acceptables, for example, comprise that tinsel 202,204 extends through housing 50 point-blank.
Subsidiary with reference to figure 2, tinsel 202,204 (being hidden among Fig. 2) extends through the proximal part 90 and the distal portions 92 of introducer 52.With respect to proximal part 90, for example, tinsel 202,204 can remain on the corresponding intracavity that is formed by this proximal part slidably; Can normally remain on single intracavity etc.In any case distal portions 92 also is configured to be convenient to tinsel 202,204 and extends to far-end 94.For example, and as the front about as described in Fig. 4, connector 102 comprises relative rib 122,124, each rib forms vertical hole 126.The size in this vertical hole 126 is made and is admitted one of corresponding metal silk 202 or 204 slidably, aligns with a corresponding hole of contiguous connector 102 in wherein corresponding each hole 126.Other various structures also are acceptables.In any case tinsel extends to the far-end 94 of distal portions 92, and individually be connected with it.For example, each tinsel 202,204 is fixed in far-end connector 182.
As in Fig. 8 schematically shown in, so first tinsel 202 (total labelling) extends along first side 222 of distal portions 92, and second tinsel 204 (total labelling) extends along the second relative side 224.By this structure, and in addition with reference to figure 3, the rotation of wheel 206 is given pulling force to one of first or second tinsel 202,204, and corresponding thrust is given tinsel 202,204 another.For example, about the orientation of Fig. 3, wheel 206 is given pulling force and is given thrust to second tinsel 204 first tinsel 202 along counterclockwise rotation (for example, user applies power upwards on control knob 208).These power are transferred on the far-end connector 182 via tinsel 202,204 again, form to promote first side 222 " towards " power of handle 50 motions (with promoting 224 motions of second side and leaving handle 50).The flexible connection or the rotating relation that comprise the connector 102 that flexibly connects framework 100 in addition make distal portions 92 can respond these push/pull and crooked or flexible connection.Therefore, as shown in Figure 9, distal portions 92 will respond that user is given control knob 208 applied forces and crooked or flexible.Especially, suction extraction channel runs/suction catheter 68 (Fig. 3) and flushing carrier pipe/irrigating catheter 74 (Fig. 3) are (perhaps in addition, extend through distal portions 92 or extend along distal portions 92) present sufficient flexibility, so that do not hinder the motion of this expectation, and show sufficient structural integrity, not kinking or fracture during with the box lunch bending.In any case first actuator 56 provides the desired locations of definite far-end 94 or the ability of the angle of attack for user, therefore kept thus by operation control knob 208 nozzles 54.This can optionally regulate nozzle 54 again by a plurality of angles of attack 226, and keeps nozzle 54 at a plurality of angles of attack 226 places, as shown in Figure 8 independently.Suction extraction channel runs/suction catheter 68, particularly suction inlet 184 (Fig. 7) are as required similarly by the different angle of optionally guiding process.
The position of rotation of nozzle 54 (and V-notch 190 and by the line jet graphics of its generation) can be controlled similarly by user or changes via second actuator 58.Specifically comprise control wheel 230, actuating device 232 and foregoing assembly parts 72 with reference to figure 3, the second actuators 58.Control wheel 230 is rotatably kept by handle 50, makes its at least a portion 234 externally expose and has nothing to do with position of rotation.In certain embodiments, it is contiguous that control wheel 230 is positioned at the mouth of pipe 62, and be arranged to be held handle 50 in addition and be easy to effect (by the finger of the hands of holding shank portion 60, perhaps by second hands of user) thereon by user.Actuating device 232 is associated with control wheel 230, and in certain embodiments, comprises first and second gears 236,238.This first gear 236 comprises skewed surface 240 and the coaxial control wheel 230 that is fixed in.Second gear 238 comprises or forms complementary skewed surface 242 (the total labelling in Fig. 3) that therefore 236,238 engagements of first and second gears engage.And second gear 238 is installed on assembly parts 72 and flushing carrier pipe 74.Because the rotation of control wheel 230, so first gear 236 rotates second gear 238 in vertical plane, wherein this rotatablely moving is passed on the flushing carrier pipe 74.As previously mentioned, flushing carrier pipe 74 is or forms the part of the irrigating catheter extend through introducer 52, and fluid ground is fixed in nozzle 54.As a result, nozzle 54 (Fig. 7) rotates along with the rotation of flushing carrier pipe 74/ second gear 238.In certain embodiments, assembly parts 72 are oscillating-type assembly parts, and therefore, with regard to as described in the operation of first actuator 56, by the flexible connection campaign of introducer 52, second gear 238 keeps engagement to engage with first gear 236 as the front.
Should be appreciated that second actuator 58 recited above just is used to realize a kind of acceptable design of rotation of the nozzle 54 of user control.Therefore, control wheel 230/ actuating device 232 can replace or comprise other parts by other parts.But, in certain embodiments, and specifically with reference to figure 8, control wheel 230 labellings 244 that comprise along its outer surface.This labelling 244 at least in part as seen in handle 50 outsides, and for user provides the visual indication of the position of rotation of nozzle 54 with respect to introducer 52, particularly, by the linear jet graphics of its generation.Therefore, for example, labelling 244 can comprise the numeral indication of the angle direction of the jet graphics that is produced by nozzle 54.But alternatively, labelling 244 can be cancelled.Consider above-mentioned explanation, after final assembling, biomembrane is removed surgical instruments 48 and is configured to provide fluid jet concentrated, pressurization or fluid stream from the far-end 94 of introducer 52 via nozzle 54.In this respect, the supply of flush fluid provides via flushing pipe/irrigating catheter 66 (Fig. 3).Equally, the suction at suction inlet 184 (Fig. 7) provides via suction extraction channel runs/suction catheter 68 (Fig. 3).Far-end 94 and therefore the space angle orientation of nozzle 54 can select via first actuator 56 (with the particularly operation of control knob 208) and change by user.Equally the spatial orientation of the line jet graphics that is produced by nozzle 54 can be rotated via second actuator 58 (with the particularly operation of control wheel 230) by user.Another example of removing surgical instruments 250 according to aspect of the present disclosure and the biomembrane that is used for system 20,20 ' (Figure 1A, 1B) is shown in Figure 10.Apparatus 250 comprises handle 252, introducer 254, nozzle 256 (total labelling) and flushing and suction catheter (not shown).Apparatus 250 can also randomly comprise first actuator 258 (total labelling) and second actuator 260 (total labelling).The details of each parts will be provided below.But generally speaking, handle 252 keeps introducer 254, and this introducer 254 is delivered to the surgery target site with being suitable for minimum invasion and attack in addition.In this respect, introducer 254 remains on its far-end with nozzle 256 and is sent by the irrigant stream (not shown) of this nozzle pressurization, removes operation to carry out biomembrane.First actuator 258 is by the bending of user operation with realization introducer 254, and second actuator 260 is exercisable, to realize motion or the rotation of nozzle 256 with respect to introducer 254.
Handle 252 is similar to foregoing handle 50 (Fig. 2), is used as the housing and the maintenance introducer 254 of the various parts of apparatus 250 usually.As the situation of handle 50, handle 250 has the shape of the pistol grip shape that forms the shank portion 262 and the mouth of pipe 264.The size and dimension of this shank portion 262 is made the grasped that is suitable for by user, and the mouth of pipe 264 is suitable for being connected in introducer 254.
With reference to Figure 11 (wherein the part of the shell body of handle 252 or shell 266 is removed, so that its internal part to be shown better), handle 252 keeps flushing pipe 268 and sucking-off or suction channel 270 in addition.This flushing pipe 268 and suction extraction channel runs 270 are extended and the guiding mouth of pipe 264 from the tail end 272 of handle 252, and introducer 254 therefore leads.As the reference point, flushing pipe 268 is shown Figure 11 and suction extraction channel runs 270 randomly can be tapered at diameter from proximal part 268a, 270a respectively, to adapt to a kind of structure of handle 252 better.And flushing pipe 268 can be set to the continuity of the fluid connector 30 shown in Figure 1A, and suction extraction channel runs 270 can be set to the continuity of the vacuum coupling 32 shown in Figure 1A.Alternatively, handle 252 can comprise respectively between flushing pipe 268 and fluid connector 30, and the suitable port organization that provides fluid to connect between suction extraction channel runs 270 and vacuum coupling 32.In any case flushing pipe 268 is used for flush fluid from fluid source 24 (Figure 1A) guiding introducer 254, and the fluid that suction extraction channel runs 270 is used for being sucked is from introducer 254 guiding vacuum sources 26 (Figure 1A).
In certain embodiments, flushing pipe 268 terminates in assembly parts 274, and assembly parts 274 are as described below in addition can be as the part setting of second actuator 260.In this respect, the first irrigation carrier pipe 276 (total labelling) extends from the opposite side of these assembly parts 274, and wherein assembly parts 274 form the fluid connection between the flushing pipe 268 and the first irrigation carrier pipe 276.The first irrigation carrier pipe 276 extends into again and by introducer 254, and fluid is connected in nozzle 256 (as described below), with common formation or formation irrigating catheter, be transported to nozzle 256 by this irrigating catheter flush fluid from fluid source 24 (Figure 1A), remove the part of operation as biomembrane.For example, the first irrigation carrier pipe 276 can be connected in the second irrigation carrier pipe (being shown in Figure 12 B with 298), and second irrigation carrier pipe fluid again is connected in nozzle 256.Alternatively, various other structures that are used for irrigating catheter are acceptable equally.For example, irrigating catheter can be directly to extend through the monolithic entity (for example, flushing pipe 268) of handle 252 and introducer 254 to nozzle 256.
Suction extraction channel runs 270 is shown among Figure 11, and it extends through handle 252 and introducer 254, and forms suction catheter, can extract out from surgical site at fluid and other material of introducer 254 far-ends by this suction catheter.But alternatively, one or more additional cast parts can be set also, to form suction catheter.
Handle 252 also keeps being similar to the triggering assembly 278 of foregoing triggering assembly 80 (Fig. 3).Therefore, trigger assembly 278 and comprise actuated piece 280, pick off 282 (total drafting) and adapter 284.For the structure and the operation that trigger assembly 278, with reference to top description to triggering assembly 80.Generally speaking, adapter 284 is suitable for carrying or transmission output from pick off 282, and connects (wired or wireless) in controller 28 by the adapter shown in Figure 1A 47.
Introducer 254 is similar to foregoing introducer 52 (Fig. 2) and extends from the mouth of pipe 264.In this respect, introducer 254 keeps flushing recited above and suction catheter along its length, and comprises or form proximal part 286 and distal portions 288.This proximal part 286 extends from the mouth of pipe 264, and distal portions 288 extends from proximal part 286, terminates in far-end 290.The characteristic of proximal part 286 is relative stiffnesses, and distal portions 288 is (with respect to rigidity of proximal part 286) flexible or that flexibly connect, to allow user control far-end 290 with respect to handle 252 motions.As how discussing, nozzle 254 remains on far-end 290 by introducer 254.
The same with the situation of the introducer 52 of Fig. 2, proximal part 286 comprises the shell 292 that supports various internal parts, for example, comprises irrigation carrier pipe/irrigating catheter 276, suction extraction channel runs/suction catheter 270, and traction tinsel 294a, 294b, shown in Figure 12 A.In this respect, flushing and/or suction catheter can be the forms of pipe (one or more) of independent formation that extends through the single chamber 295 of housing 292 as shown.Alternatively, housing 292 can form a plurality of chambeies, and suction extraction channel runs 270, irrigation carrier pipe 276 and traction tinsel 294a, 294b are held individually in wherein.Along these identical pipelines (line), the chamber of housing 292 (one or more) can be as one of flushing and/or suction tube (one or more) or both parts.As the reference point, traction tinsel 294a, 294b describe in more detail about first actuator 258 (Figure 10) below.
Return Figure 11, distal portions 288 is flexible, and wherein this flexibility is given by the framework 296 that flexibly connects in certain embodiments.Shown in Figure 12 B, framework 296 is suitable for supporting the various internal parts that extend through it, comprises that suction extraction channel runs 270 is with traction tinsel 294a, 294b.In some structures, distal portions 288 comprises the second irrigation carrier pipe 298.With reference to figure 12A, the second irrigation carrier pipe, 298 fluids are connected in the first irrigation carrier pipe 276 in addition, and wherein the second irrigation carrier pipe, 298 to the first irrigation carrier pipes 276 are flexible more.For example, in certain embodiments, the first irrigation carrier pipe 276 (it extends through proximal part 286 in addition and enters in the handle 252) is made of stainless steel material, and the second irrigation carrier pipe 298 is braiding Pebax TMPipe.As described below, the flexibility of the second irrigation carrier pipe 298 conducts to the flexible connection of distal portions 288.On the contrary, the rigidity of the first irrigation carrier pipe 276 promotes or is convenient to nozzle 256 to rotate with respect to the expectation of introducer 254.Under the situation of this embodiment,, irrigation carrier pipe 276,298 forms at least a portion of irrigating catheter recited above so making up.But, again, being connected with the fluid of nozzle 256 in formation, other structure also is an acceptable.
As the situation of front embodiment, framework 296 is made of a plurality of connectors 300, and it comprises intermediate connector 300a, near-end connector 300b and far-end connector 300c.The contiguous connector of connector 300 is connected to each other rotationally or hingedly in the mode that allows relative motion, and is as described below.
Additionally with reference to figure 13A, each intermediate connector 300a comprises the framework 302 that forms first side 304 and second side 306.First and second flanges 308,310 form along first side 304, and first and second grooves 312,314 form along second side 306.In certain embodiments, first and second flanges the 308, the 310th, identical, also be identical as groove 312,314, wherein lip/recess forms on the opposite end 316,318 of framework 302 respectively 308/312,310/314.In this respect, the longitudinal extension that flange 308,310 forms with respect to framework 302 terminates in crooked or convex surface 320.First and second grooves 312,314 form surface 322 crooked or spill again.As described in greater detail below, convex and concave surface 320,322 have shape corresponding or coupling, make to form the translation relation of engagement after connector 300a is assemblied on the second connector (not shown).
Framework 302 also forms first and second passages 324,326.The size of first passage 324 is fit to admit irrigating catheter (for example, the second irrigation carrier pipe 298 of Figure 12 B), and the size of second channel 326 is fit to admit suction catheter (for example, the suction extraction channel runs 270 of Figure 12 B).In this respect, though first and second passages 324,326 relative to each other open wide, Figure 13 A embodiment wherein, can form part convex shoulder 328, it is suitable for catching slidably the irrigating catheter/irrigation pipe 298 relevant with first passage 324, with the suction catheter/suction extraction channel runs 270 relevant with second channel 326.Framework 302 can form single passage (for example, can cancel convex shoulder 328), or passage 324,326 can relative to each other seal but alternatively.Even further, a plurality of in other embodiments discrete passages form or are formed in the framework 302 by framework 302.
At last, framework 302 forms or constructs first and second vertical hole 330a, the 330b.Hole 330a, 330b form in relative mode with respect to framework 302, and randomly close on setting with part convex shoulder 328, so that minimize the integral width of connector 300a.In this respect, the size of hole 330a, 330b is fit to admit slidably one of traction tinsel 294a, 294b (Figure 12 B), and is as described below.
Near-end connector 300b is illustrated in greater detail among Figure 13 B and comprises bottom 322, annular lip 334 and connector main body 336.Additionally with reference to Figure 11, bottom 332 is tubular, is configured for being installed on the proximal part 286 of introducer 254.Flange 334 radially extend with respect to bottom 332 and after being assemblied in proximal part 286 as abutment surface.At last, connector main body 336 is similar to foregoing intermediate connector 300a (Figure 13 A), and therefore comprises flange 308,310, passage 324,326 and foregoing vertical hole 330a, 330b.
Far-end connector 330c is illustrated in greater detail among Figure 14.As previously mentioned, far-end connector 330c comprises the framework 338 that forms groove 312,314 and vertical hole 330a, 330b.Framework 338 terminates in sealing surface 340 places of the far-end 290 that can be used as introducer 254 in addition.Framework 338 also forms passage 342, and its size is fit to rotatably keep nozzle 256.Passage 342 is suitable with the first passage 324 (be hidden among Figure 14, but be shown among Figure 13 A) of intermediate connector 300a, makes nozzle 256 to align with the irrigating catheter by its supporting.Equally, suction inlet 344 is formed, and it is suitable with the second channel 326 relevant with intermediate connector 300a (total labelling among Figure 14, and the most clearly be shown among Figure 13 A).Therefore, 344 fluids are connected in (or support) suction catheter (for example, the suction extraction channel runs 270 of Figure 12 B) but suction enters the mouth.
After final assembling, and with reference to Figure 11 and Figure 14, connector 300 is assemblied on second irrigation carrier pipe 298 (Figure 12 B) and the suction extraction channel runs 270 (Figure 12 B), and wherein near-end connector 300b is assemblied in the front end 346 of proximal part 286.Intermediate connector 300a assembles continuously away from near-end connector 300b.In this respect, flexible connection is closed to tie up between it and is formed.For example, with respect to the first and second intermediate connector 300a ', the 300a that discern among Figure 14 ", first flange 308 of the first connector 300a ' rotatably is embedded in the second intermediate connector 300a " first groove 312 in.Though be hidden among Figure 14, same pass ties up to second flange and the second intermediate connector 300a of the first intermediate connector 300a ' " second groove between form.Distal portions 288 terminates in far-end connector 300c, and it is rotatably related with the flange 308,310 of the intermediate connector 300a of adjacent distal end connector 300c via groove 312,314 in addition.
As shown in the figure, far-end connector 300c keeps nozzle 256.In certain embodiments, nozzle 256 can be identical with previously described nozzle 54 (Fig. 7), therefore saves its detailed description.Generally speaking, and specifically with reference to Figure 14, nozzle 256 is configured to produce the jet graphics of fan shape, and rotatably remains on passage 342 places by far-end connector 300c, or is assemblied in far-end connector 300c at passage 342.The jet graphics of this fan shape produces via the V-notch 348 at preceding hemispherical end 350 places that are formed on nozzle 256.In certain embodiments, and as shown in figure 14, V-notch 348 forms along a side 352 of nozzle 256 and extends, so that produce side-looking jet graphics (rotation by nozzle 256 therefore as described below covers more area).Alternatively, this V-notch 348 can form with respect to the axis centre ground of nozzle 256.Even also have, various other structures that are used for nozzle 256 also are acceptables.
Turn back to Figure 11, first actuator 258 is configured to provide with respect to handle 252 motion or the flexible connection of the introducer distal portions 288 of user control, and comprise that in certain embodiments actuator 354 and traction tinsel 294a, 294b (save from the view of Figure 11, but be shown in, for example among Figure 12 A).As described below, the first and second traction tinsel 294a, 294b are assemblied in actuator 354 and extend to introducer 254.By this structure, the Motion Transmission of actuator 354 is on tinsel 294a, 294b, and it realizes the motion of introducer 254 with respect to handle 252 again, and particularly distal portions 288 with respect to the motion of handle 252.
In certain embodiments, actuator 354 comprises control wheel 356 and relative convex shoulder 358 (one of them is shown among Figure 11).As Figure 10 clearly shown in, this control wheel 356 rotatably is assemblied in handle 252, its part is protruding with respect to handle 252.Because this structure, so control wheel 356 can be with other grasps handle 252 effects of cause user (not shown), by user, for example by the finger and/or the thumb of user.In any case wheel 356 is rotatable around central point 360, and can comprise feature (not shown) with respect to handle 252 these wheels of selective lock (for example, above about actuator 56 described balls and the groove mechanism of Fig. 3).
Convex shoulder 358 extends with axial direction roughly from wheel 356 with respect to central point 360, and each forms slit 362, and the size of slit 362 is fit to admit one of corresponding traction tinsel 294a, 294b (omit, but be shown in Figure 12 A) from Figure 11.In this respect, far-end and near- end gap 363a, 363b (total labelling) are formed between the convex shoulder 358, and its size is suitable for by the first irrigation carrier pipe 276.Because this structure is so as described below, the first irrigation carrier pipe 276 extends to assembly parts 274 by actuator 354.In addition, gap 363a, 363b form enough intervals, the irrigation carrier pipe 276 of winning is not hindered or hinder 356 rotations around central point 360 of control wheel.In any case, and as mentioned above, traction tinsel 294a, 294b extend and pass through introducer 254 from one of corresponding convex shoulder 358.For example, traction tinsel 294a, 294b extend through one of vertical hole 330a, 330b (Figure 12 B) of being formed by connector 300.In any case traction tinsel 294a, 294b extends to and be connected in far-end connector 300c.
With reference to Figure 15, the operation of first actuator 258 comprises the power that the user on the control wheel 356 applies that acts on.The rotation of control wheel 356 is applied to pulling force on one of the first or second traction tinsel 294a, 294b (Figure 12 B), and corresponding thrust is applied on another of tinsel 294a, 294b.This push/pull is delivered to again on the far-end connector 300c.The flexible connection or the rotatable relationship that comprise the connector 300 of movable connecting frame 296 in addition respond this push/pull and make the distal portions 288 can be crooked or flexibly connect.As a result, as mentioned above, distal portions 288 is with bending or deflection, shown in the arrow among Figure 15.In order to help the flexible connection degree of user remote evaluation distal portions 288 (insert in addition in the body structure and therefore from the direct vision of user, hide) better with introducer 254, control wheel 356 can also comprise indicator 364, and handle 252 can comprise labelling 366.Labelling 366 provides angle indication or the degree that flexibly connects; By this structure, so, by aliging, aliging with one of corresponding labelling 366 with indicator 364, user can be estimated the degree of distal portions 288 bending or deflection.Alternatively, first actuator 258 can be taked various other forms.
Return Figure 11, the spin orientation of 260 pairs of nozzles 256 of second actuator provides control, and it comprises control wheel 368 and assembly parts 274.Control wheel 368 is rotatably kept by handle 252, makes externally to expose (so the user of apparatus 250 can be approaching) in its at least a portion 370 of any position of rotation (as shown in figure 10) (clearly being shown in Figure 10).In any case control wheel 368 is fixed in the first irrigation carrier pipe 276, as previously described, this first irrigation carrier pipe 276 randomly is a relative stiffness.And assembly parts 274 are configured to provide mode constant, fluid-tight rotatably to admit the first irrigation carrier pipe 276.Because this structure is so the rotation of control wheel 368 passes to the first irrigation carrier pipe 276.Assembly parts 274 allow the first irrigation carrier pipe 276 with wheel 368 rotations, keep fluid to be connected with flushing pipe 268 simultaneously always.As previously described, the first irrigation carrier pipe 276 extends through introducer 254, particularly, and by proximal part 286.And the first irrigation carrier pipe 276 is installed on the second irrigation carrier pipe 298 (Figure 12 B).Therefore, the rotation of the first irrigation carrier pipe 276 passes to the second irrigation carrier pipe 298, and this second irrigation carrier pipe 298 is connected in nozzle 256 again.Like this, nozzle 256 is passed in the rotation of control wheel 368.Alternatively, second actuator 260 can be taked various other forms, and in certain embodiments, can be cancelled.
Turn back to Figure 1A, () definite structure-irrelevant for example, the apparatus 48 of Fig. 2, the apparatus 250 of Figure 10, or remove instrument configurations by this unsettled open other biomembrane of being predicted, other parts of system 20 can be taked various forms to remove apparatus 22 with biomembrane.For example, fluid source 24 can comprise the pump 380 that is connected in container 382.In certain embodiments, pump 380 is peristaltic pumps, and those pumps that for example are generally used for being associated with surgery and endoscopic surgery are as described below, and pump 380 is used for being 22 the fluid stream pressurization from container 382 to apparatus.Container 382 can comprise one or more IV bags of for example filling with irrigation, comprise the U.S. Patent Application Serial 11/431 that on May 10th, 2006 submitted to, irrigation fluid described in 495, the name of this application is called " Biofilm ExtracellularPolysaccharide Solvating (EPS) System ", and its whole content is incorporated into that this is for reference.In certain embodiments, irrigation comprises medicine---comprise those medicines that are suitable for disturbing the bacterial biof iotalm regrowth, surfactant, gel, antibacterial, steroid, growth hormone, be used to reduce the chemicals of biomembrane bonding force and other.
Fluid source 24 is connected in apparatus 22 via fluid connector 30, and fluid connector 30 is pipeline group in certain embodiments.For example, as previously described, fluid connector 30 for example can be communicated with flushing pipe 66 (Fig. 2), 268 (Figure 11) fluid by the port (not shown), and this port is communicated with nozzle 44 fluids again.And adapter 32 can comprise auxiliary entrance or port (not shown), is used for medicine is incorporated into from fluid source 24 effusive irrigation (not shown), for example foregoing those medicines.
Vacuum source 26 (total labelling) is suitable for providing suction streams or vacuum-flow via vacuum coupling 32 for apparatus 22.Vacuum source 26 can comprise the collecting tank 384 that negative pressure source (not shown) fluid is connected in vacuum coupling 32.Vacuum coupling 32 is arranged to be communicated with suction extraction channel runs/suction catheter 68 (Fig. 2), 270 (Figure 11) and negative pressure source 26 fluids, or forms their part.Suction extraction channel runs/suction catheter 68,270 again with form by introducer 42 or be communicated with by suction inlet 184 (Fig. 7), 344 (Figure 13 C) fluid that introducer 42 keeps.By this way, suction inlet 184,344 is communicated with vacuum source 26 fluids, makes suction streams to be " pulled " out by suction extraction channel runs/suction catheter 68,270.In addition, in certain embodiments, collecting tank 384 is used to be collected in fragment and other material that apparatus aspirated between 22 operating periods as the blood processor such as treatment box, is included in common those used materials in surgery and/or the endoscopic surgery.
As previously mentioned, the operation of controller 28 control system 20, and be designed to physically be associated with fluid source 24, although controller 28 randomly be independent device or with any other system element physical interconnection, comprise, for example with the adapter 47 that has apparatus 22 to provide.Controller 28 can take to carry out various function various forms, and can comprise microchip, memorizer and/or other suitable controller electronic installation.
Controller 28 is arranged to communicate by letter with apparatus 22 and fluid source 24.For example, controller 28 can be electrically connected on the triggering assembly 45 of apparatus 22 by adapter 47.Controller 28 can also be arranged to directly or indirectly communicate by letter with fluid source 24 and/or vacuum source 26 via wiring or optional suitable device, for example, utilizes transmitting set and receptor.In any case in certain embodiments, the actuating that triggers assembly 45 sends signal to controller 28, controller 28 activates fluid source 24 again, to provide irrigant stream according to hope to apparatus 22.In certain embodiments, controller 28 can also be controlled the operation of vacuum source 26 directly or indirectly.In other structure, along these circuits, controller 28 can be programmed, or is suitable for flushing and/or extraction curve (profile) operating system 20 according to various expectations, comprises the flow pattern of slope braking (ramp actuation), time delay, variation etc.For example in certain embodiments, system 20 can also comprise the foot switch 386 that is electrically connected on controller 28 or similarly install that wherein foot switch 386 is by the operation of user (not shown) operation with control device 22, fluid source 24 and/or vacuum source 26.In other embodiments, foot switch 386 can be directly connected in vacuum source 26, is used to control its operation.
As mentioned above, some embodiment that remove system according to surgery biological film of the present disclosure also comprise the endoscope 34 shown in the system 20 ' of Figure 1B.Endoscope 34 can be a type well known in the art, and generally includes the various opticses that are suitable for the imaging internal body structure.Generally speaking, endoscope 34 comprises the insertion portion 390 of handle 388 and formation working end 392.This insertion portion 390 is suitable for being arranged on human body the inside, and wherein be located at will be by the target site of imaging in working end 392." imaging ", " being suitable for imaging " and similar language should be understood to comprise that the optics by endoscope 34 is directly visual, and via the electronics of electronic imaging visual and/or data analysis, for example, utilize imaging device 38 or other electronic installation.
In many endoscopies structure, light source 36 is arranged at endoscope 34, and endoscope arrives working end 392 with guiding light emitted, to throw light on by the internal body structure of imaging or other target site, wherein associated picture or view data 392 are transmitted from the working end, and are transferred to imaging device 38 via endoscope 34.
Consider above-mentioned situation, imaging device 38 randomly is the imageing sensor such as video camera, display and/or other imaging electronics, comprises those devices that use together at endoscopic surgery usually.Imaging device 38 can be independent parts, perhaps can be connected in controller 28.In any case, and as conventionally known, imaging device 38 and endoscope 34 be used for before the surgical operation that utilizes apparatus 22 to carry out, during and/or imaging afterwards.
Whether guard system 20,20 ' is not equipped with endoscope 34 and relevant parts 36,38, and the surgery biological film is removed system 20,20 ' and can be used for carrying out various operations at patient's the various regions of anatomy.As an example, Figure 16 illustrates patient's internal body structure 400, comprises the hole chamber such as maxillary sinus 410a, 410b and preceding hole 412a, 412b, and it arrives by nostril 414a, 414b.The surface that should be noted that the patient who comprises nostril 414a, 414b is shown in broken lines.In order to describe the surgery hands method of removing biological membranous layer basically,, first target site 416 relevant with the surface of maxillary sinus 410a is shown for utilizing system 20, some operations (for example, suffering from the patient of chronic sinusitis) of 20 '.But, should be appreciated that same principle is applied to all embodiment, comprise the various target sites that are associated with various internal body structure, such as hole chamber (for example, maxillary sinus chamber, preceding hole chamber, wedge shape hole chamber etc.), ear chamber (tympanum and other chamber) etc.Consider this point, in certain embodiments, first target site 416 is the cilium epidermises with maxillary sinus 410a of Related Bacteria layer and associated biomolecule film (not shown).In other embodiments, target site 416 is man-made structures, such as the hole choke material or the support that are covered by the bacterium living beings rete.
In conjunction with reference to Figure 1A and Figure 16, and consider foregoing system 20, the certain methods of removing the bacterial biof iotalm (not shown) from target site 416 (or any other target site of patient inside) comprises: system 20 is set; The introducer 42 of apparatus 22 is inserted among the maxillary sinus 410a; With nozzle 44 these target sites 416 of aiming; Carry the irrigant stream (not shown) of pressurization from nozzle 44 to target site 416, to destroy and to remove substantial amount (in a large number's) bacterial biof iotalm; And via suction inlet 184 (Fig. 7), 344 (Figure 14) with irrigation, the biomembrane that is removed and/or the suction of body exudates (not shown) away from target site 416.Can adopt apparatus 48 (Fig. 2) or 250 (Figure 10) any (other structure that also can enough disclosure can predict) in the described below method, therefore with reference to the general introduction instrument configurations 22 of Figure 1A and 1B.
In certain embodiments and in addition with reference to Figure 1B, provide endoscope 34 and relevant parts 36,38, and it is used to suitably locate introducer 42/ nozzle 44 with respect to target site 416.Along these identical circuits, before inserting introducer 42, or when inserting introducer 42, also carry out Functional endoscopic operation on nasal sinus (FESS).For example, as the part of EFSS operation, endoscope 34 and/or apparatus 22 randomly are suitable for, and/or use according to expectation and other instrument combination, arrive target site.
According to some embodiment, system 20 or 20 ' is set comprises endoscope 34 is connected in light source 36 and imaging device 38.Equally, apparatus 22 suitably is connected in fluid source 24 and vacuum source 26.In this respect, being connected and realizing via controller 28 between apparatus 22 and the fluid source 24.In any case apparatus 22 is electrically connected on controller 28.In addition, in certain embodiments, around the sterile barrier 420 (schematically illustrating among Figure 1A, the 1B) of apparatus and patient's setting such as other article commonly used in cloth list or surgical operation and/or the endoscopic surgery, to help to keep sterile working's environment.
Just as mentioned above, be described with reference to maxillary sinus 410a and target site 416 with some embodiment that remove biological membranous layer though act on the target site, but be to be understood that, in the biomembranous removal of other target site that comprises hole chamber or tympanum (not shown) and/or other inner chamber, can carry out in essentially identical mode.Consider this point, endoscope 34 originally randomly be used for before apparatus 22 operation, during and/or imaging target site 416 or other internal body structure afterwards.Though the apparatus 22 (particularly, introducer 42) that has only that is illustrated in Figure 16 is inserted among the maxillary sinus 410a, both can place maxillary sinus 410a (or other body cavity) simultaneously to should be appreciated that in certain embodiments endoscope 34 and introducer 42.
In any case, introducer 42 inserted comprise among the maxillary sinus 410a that practitioner's (not shown) catches handle 40 (Figure 1A) and distal portions 418 is inserted among the 414a of nostril and towards maxillary sinus 410a.In this respect, under situation about providing, in order to help the practitioner to guide nozzle 44 and/or with nozzle 44 aiming target positions 416, before introducer 42 inserts, during or afterwards, endoscope 34 is similarly inserted and is obtained image (via imaging device 38).
In addition with reference to figure 9 and Figure 15, distal portions 418 is optionally crooked or (for example flexibly connect by user then, first actuator 56 via Fig. 9, or first actuator 258 of Figure 15), with along direction " aiming " nozzle 44 of expectation and/or be convenient to among the introducer 42 insertion maxillary sinus 410a.When nozzle 44 arrived target site 416, distal portions further flexibly connected, to guide the angle of attack that is formed with respect to target site 416 by nozzle 44.In this respect, the practitioner via endoscope 34 and imaging device 38 can judge nozzle 44 whether with respect to target site 416 by suitably " aiming ", perhaps in other words whether suitably arranged.In certain embodiments, the practitioner for example, by judging the image that shows via 38 pairs of user of imaging device, can discern target site 416 by observing the existence/position of biological membranous layer.
In case after the hope location, then, the user (not shown) impels the irrigant stream of carrying pressurization to target site 416, to realize removing or eradicating the bacterial biof iotalm (not shown) of real mass by squeeze-activated device 46 from target site.Respond this actuating, signal is sent to controller 28, and controller 28 impels the startup of fluid source 24 again, also therefore to provide irrigant stream by nozzle 44 by irrigating catheter recited above.What take into account is, according to each embodiment with various flow rates guiding irrigant stream through nozzles 44, comprise from about 2ml/ second to about 12ml/ flow velocity of second.In certain embodiments, system 20,20 ' is suitable for producing stream of pulses and other basic Continuous Flow by nozzle 44, and still in certain embodiments, produces the flow pattern that is different from stream of pulses or basic Continuous Flow.
From the direct impact target of the irrigant stream position 416 that nozzle 44 distributes, perhaps other direct aggression target site 416 is mechanically to stir or to destroy and remove essential part or whole substantially biomembrane (not shown).In other words, when with introducer 52,254 fully near the time, nozzle 44 can be directed pointing as previously mentioned at target site 416, so that finish machinery " scraping " effect.The pressure and/or the flow rate that should be pointed out that irrigation are chosen to promote biomembranous machinery removal and do not damage following tissue basically, such as Ciliated epithelium's layer.For example, can select the following pressure of about 50psi, though other pressure also is acceptable.
Because from the successive pressure flush agent stream of nozzle 44, user is via actuator (for example, second actuator 58 of Fig. 2, or second actuator 260 of Figure 11) swivel nozzle 44 periodically and/or continuously randomly.As previously described, in certain embodiments, nozzle 44 produces capable, the fan-shaped spray figure of line; Because the rotation of nozzle 44, so the path is " inswept " or stride across target site 416 effectively, makes introducer 42 can keep relative fixed, handles big relatively area simultaneously.Utilize this method, the ability of accurately locating nozzle 44 with respect to target site 416 is not very important, because the pressure flush agent of carrying from nozzle 44 can act on big relatively surface area.In fact, in certain embodiments, big relatively processing area reduces the needs to the endoscope with complex optical components, and in fact, can eliminate the needs of 22 pairs of accurate endoscopies of apparatus.But alternatively, nozzle 44 can take various other structure and/or do not need to provide ability with respect to introducer 42 swivel nozzles 44.In certain embodiments, for example, during target site 416 is distributed the irrigation (not shown) and/or afterwards, the suction utilization of bacterial biof iotalm, antibacterial, mucus, secretions, thanatogenic tissue or other material of not expecting suction inlet 184 (Fig. 7), 344 (Figure 14) finish.For example, response user operate actuator 46 and/or foot switch 386 carry out simultaneously with flushing and/or some time differences (for example, before or after the flushing) are arranged, and operating apparatus 22 is selectively or continuously to start vacuum source 26.When randomly guiding to the biological collecting tank 384 that is associated with vacuum source 32 in addition, near the material of not expecting target site 416 is removed.
Above-described system and method is very useful in the relevant various diseases of surgical intervention and multiple different and the region of anatomy or target site.For example, except sinus tract and internal ear target site, system and method for the present disclosure can be used in the target site of treatment patient pulmonary (for example, the respiratory epithelium tissue of gallbladder cystic fibrosis and pulmonary), urinary tract and/or department of obstetrics and gynecology (for example urinary tract infection) etc.
System and method of the present disclosure provides tangible improvement to previous technology and the device that is used for the treatment of such as the various diseases of chronic sinusitis.By utilizing concentrated pressure fluid to realize the biomembrane elimination, on the basis of minimum invasion and attack, provide treatment more completely to the patient.And, under the situation of hole and other application, drainage pathway (one or more) be resumed, the ventilation (ventilation) that therapentic part is provided (therefore, minimize the chance of biofilm), and can provide other functional and endoscope's operation on nasal sinus treatment (for example, local application, flushing etc.).
In view of the foregoing, according to some embodiment, provide the method for utilizing the endoceliac internally target site of apparatus 22 (for example apparatus 250 of the apparatus 48 of Fig. 2 or Figure 10) to eradicate bacterial biof iotalm.Should be pointed out that according to other relevant embodiment those embodiment that are associated with Figure 17-22 that for example are described below, system 20,20 ' various functions and advantage is optional is provided.
Figure 17 illustrates according to the biomembrane of some embodiment and removes surgical instruments 450, and wherein apparatus 450 comprises the feature that is used to admit endoscope 452.Apparatus 450 is substantially similar to apparatus 22 (Figure 1A), and wherein corresponding components comprises handle 460, actuator (not shown), comprises introducer 462, irrigating catheter 466 and the suction catheter 468 of flexible distal portions 464.Apparatus 450 comprises also or forms the endoscopic catheters 470 that extends through introducer 462 that wherein handle 460 is formed for admitting slidably endoscope's port 476 of endoscope 452.For reference, Figure 17 illustrates the side view of apparatus 450, wherein understands in order to help, and the part of handle 452 and introducer 462 is removed.
With reference to Figure 17 and Figure 18, introducer 462 can be similar to introducer 42 (Figure 1A), and forms endoscope's guide (not shown), and it randomly comprises the optical window 478 of the working end (not shown) that is used to protect endoscope 452.Endoscopic catheters 470 randomly is hollow pipe or the sleeve pipe that extends between endoscope's port 476 and endoscope's guide.Should also be noted that according to some embodiment endoscopic catheters 468 is formed by the inside of handle 460 and introducer 462, or form by its part.
In use, endoscope 452 inserts in endoscope's port 476 and slides through endoscopic catheters 468, makes the working end (not shown) be arranged in endoscope's guide, and suitably contiguous or close optical window 478.Endoscope 452 randomly is suitable for releasedly the part coupling with endoscope's port 476 and/or handle 460, perhaps fixes releasedly with it in addition.
As mentioned above, be associated with some embodiment of apparatus 22, apparatus 450, particularly, the distal portions 464 of introducer 462, by being similar to a plurality of angles of attack of apparatus 22, randomly be suitable for activateding or selectively bending, to guide to the target site guiding irrigation of expectation and/or to the target site of expecting) suction streams.In certain embodiments, endoscope 452 is flexible endoscopies, so as the working end (not shown) that the selectivity bending of introducer 462 also makes endoscope 452 carry out biomembrane remove operation before, during or afterwards by aiming at imaging target site such as target site 416 (Figure 16).
Figure 19 illustrates according to the another kind of biomembrane of some embodiment and removes surgical instruments 500, wherein apparatus 500 comprises those the feature that is similar to apparatus 450 (Figure 17 and Figure 18) that is used to admit endoscope 502, and is suitable for inserting in the body cavity flexibly as flexible conduit.Particularly, apparatus 500 is substantially similar to apparatus 450, and wherein corresponding components comprises handle 510, introducer 512, actuator 513 (total labelling), irrigating catheter (not shown), suction catheter (not shown) and endoscopic catheters (not shown).Introducer 512 comprises distal portions 514 and proximal part 516.For example, as described in conjunction with other embodiment of front, the size and dimension of proximal part 516 and distal portions 514 is made and is suitable for being used as flexible conduit in addition, and wherein distal portions 514 is configured to alternative the flexible connection.Introducer 512 terminates in far-end 518.As shown in figure 20, far-end 518 randomly supports nozzle 520 (total illustrates), and this fluid nozzle is connected in the irrigating catheter (not shown), and it extends through introducer 512 in addition.In addition, Figure 20 illustrates suction catheter 522.With reference to Figure 19 and Figure 20, introducer 512 is similar to introducer 462 (Figure 17), and forms endoscope's guide (not shown), and it randomly comprises the optical window 524 (Figure 20) of the working end (not shown) that is used to protect endoscope 502.The endoscopic catheters (not shown) randomly is hollow pipe or the sleeve pipe that extends between endoscope's port 526 (Figure 19) and endoscope's guide (not shown).Should also be noted that according to some embodiment endoscopic catheters is formed by the inside of handle 510 and introducer 512, or form by its part.
In use, endoscope 502 inserts in endoscope's port 526 and slides through the endoscopic catheters (not shown), makes the working end (not shown) be arranged in endoscope's guide (not shown), and suitably contiguous or close optical window 524.Endoscope 502 randomly is suitable for releasedly the part coupling with endoscope's port 526 and/or handle 510, perhaps fixes releasedly with it in addition.
As mentioned above, apparatus 500, particularly distal portions 516 is flexible basically and can be used as flexible conduit, to arrive the inner body cavity structure.In certain embodiments, distal portions 514 is suitable for activateding or is optionally crooked by being similar to a plurality of angles of attack of apparatus 22 (Figure 1A), to guide suction streams to the target site guiding irrigation of expectation and/or to the target site of expecting.In certain embodiments, endoscope 502 is flexible endoscopies, make working end (not shown) that the crooked liquid of selectivity of apparatus 500 allows endoscope 502 carry out biomembrane remove operation before, during or afterwards by aiming at imaging target site such as target site 416 (Figure 16).
Figure 21 illustrates according to some embodiment with side view and is used for removing surgical instruments 600 with the another kind of biomembrane that endoscope's (not shown) uses, and wherein apparatus 600 comprises irrigating catheter 602, suction catheter 604 and endoscopic catheters 606.Each conduit 602,604,606 forms elongated, hollow and piped parts.Conduit 602,604,606 forms irrigation ports 610, suction ports 612 and endoscope's port 614, is used to be connected in the above remove system unit about the bacterial biof iotalm of the described correspondence of system 20 (Figure 1A).Conduit 602,604,606 is relative to each other fixing, and is combined to form the proximal part 620 and the distal portions 622 of apparatus 600.Irrigating catheter 602 forms or maintenance nozzle 624.Suction catheter 604 forms arrival end 626, is used for extracting material out from target site 416 (Figure 16).Endoscopic catheters 606 is suitable for again admitting endoscope's (not shown) and randomly comprising the optical window 628 that is used to protect endoscope during use.
With reference to Figure 21 and Figure 22, distal portions 622 is with respect to closely forming sweep 630 by the apparatus 600 independent proximal parts that keep.In certain embodiments, one or more conduits 602,604,606 or its part are inflexible basically, make that sweep 630 is kept independently.In certain embodiments, one or more conduits 602,602,604,606 are malleable basically, make sweep 630 or additional sweep (not shown) to form and are kept independently by apparatus 600.
In use, endoscope's (not shown) inserts in endoscope's port 614 and slides through endoscopic catheters 606, makes the working end (not shown) of endoscope be close to or close optical window 628.Endoscope 602 randomly is suitable for releasedly port 614 couplings with endoscope, perhaps fixes releasedly with it in addition.In certain embodiments, endoscope 602 is flexible endoscopies, make the rigid curved part comprise apparatus 600 or the sweep 630 of a plurality of sweep or malleable sweep (or a plurality of sweep) in the insertion tube (not shown) of endoscope, produce corresponding sweep, with respect to the target site aiming of expectation and keep enter the mouth 626 the angle of attack of endoscope working end, nozzle 624 and far-end.
Though described the present invention with reference to preferred embodiment, it will be appreciated by those skilled in the art that under the situation that does not break away from the spirit and scope of the present invention, can carry out various variations in the form and details.For example, conduit tube component as described herein is to be used for the optional feature that biomembrane is removed system, and therefore can be cancelled, as also cancelling the same with one or more other parts that surgical instruments is separated.

Claims (27)

1. system that is used for removing bacterial biof iotalm from the target site of human patients, this system comprises:
Be used for removing from described target site the surgical instruments of bacterial biof iotalm, described apparatus comprises:
Be suitable for the elongated introducer in the minimum invasion and attack surgery insertion human patients body, described introducer comprises proximal part and terminates in the distal portions of far-end, described distal portions is convertible with respect to described proximal part between a plurality of angle of bend, and wherein said apparatus is suitable for independently described distal portions being remained on respect to described proximal part each angle place of a plurality of angle of bend;
Be used to carry the irrigating catheter of irrigation; With
With the nozzle that described irrigating catheter fluid is communicated with, described nozzle is held with respect to the distal portions of described introducer, and is suitable for from the fluid of described irrigating catheter to bacterium living beings rete dispense pressurised, destroys described bacterium living beings rete with described from target site.
2. system according to claim 1 also comprises:
Endoscopic system, it comprises endoscope and imaging device.
3. system according to claim 1 also comprises:
Vacuum source; With
With the suction catheter that described vacuum source fluid is communicated with, described suction catheter extends through described introducer and ends at the suction inlet that is used for from described target site suction material.
4. system according to claim 1, the proximal part of wherein said introducer is inflexible basically, the distal portions of described introducer is flexible basically, and described apparatus also comprises:
Actuator, it is suitable for making the distal portions of insertion portion to change between the angle of a plurality of bendings.
5. system according to claim 4, wherein said apparatus also comprises:
The handle that keeps actuator; With
Further, wherein said actuator comprises:
Each all is fixed in first tinsel and second tinsel of the distal portions of described introducer;
With respect to the rotatably fixed wheel of described handle;
Wherein said distal portions forms first side and second side relative with described first side; And further, wherein said first tinsel mechanically connects first side of described wheel and described distal portions, and described second tinsel mechanically connects second side of described wheel and described distal portions.
6. system according to claim 5, wherein said distal portions comprises a plurality of connectors that are rotatably connected.
7. system according to claim 6, wherein each connector comprises framework and relative flange.
8. system according to claim 1, at least a portion of wherein said introducer flexibly connects basically, make that described distal portions is suitable for changing between a plurality of angle of bend with respect to described proximal part, and remain on a plurality of angle of bend place independently.
9. system according to claim 1, wherein said nozzle is rotatably mounted in described introducer.
10. system according to claim 9 also comprises:
Actuator, it is suitable for selectively rotating described nozzle with respect to described introducer.
11. system according to claim 10, wherein said apparatus also comprises the handle that keeps described introducer, and further, wherein said actuator comprises:
Rotatably be fixed in the wheel of described handle;
The rigidity irrigating catheter part that is connected in described wheel and extends from described wheel; And
The flexible irrigating catheter part of between described rigidity irrigating catheter part and described nozzle, extending.
12. system according to claim 1, wherein said nozzle is configured to produce fan type jet graphics.
13. system according to claim 1, wherein said introducer terminates in the distal face place, and further, wherein said nozzle stretches out from described distal face, and is arranged to guide irrigation along the direction away from described distal face from described irrigating catheter.
14. the method from the target site destruction bacterial biof iotalm of human patients, this method comprises:
Provide bacterial biof iotalm to remove system, this system comprises:
Surgical instruments, described apparatus has the distal portions that comprises proximal part and terminate in far-end, described distal portions flexibly connects with respect to described proximal part, the nozzle that wherein said introducer keeps irrigating catheter and is communicated with described irrigating catheter fluid, wherein said nozzle is arranged on described far-end;
The distal portions surgery of described introducer is inserted among the patient;
Described nozzle is delivered near the described target site, and described target site comprises the bacterium living beings rete that is adhered to the surface; And
By the irrigant stream of described nozzle, from described surface, mechanically to remove most bacterium living beings rete to described target site dispense pressurised.
15. method according to claim 14, described method also comprises:
The described far-end that flexibly connects with respect to ground, the handle space of described apparatus is to regulate the angle of attack of described nozzle.
16. method according to claim 15, wherein the described far-end of ground, space flexible connection comprises:
With respect to described target site described nozzle is delivered to first position, to form first angle of attack of described nozzle with respect to described target site;
Estimate the efficient of described first angle of attack;
Activate the actuator of patient outside,, thereby the angle of described nozzle is adjusted to second angle of attack from described first angle of attack with the bending of realization distal portions.
17. method according to claim 14 also comprises:
Rotate described nozzle with respect to described introducer after near described nozzle being delivered to target site.
18. method according to claim 17, wherein when the described nozzle of rotation, described fluid distributes from described nozzle.
19. method according to claim 14, wherein said apparatus has suction catheter, and described suction catheter extends through described introducer and terminates in the suction porch of contiguous described nozzle, and this method also comprises:
The bacterial biof iotalm that suction is removed through described suction inlet and the irrigation of distribution.
20. method according to claim 14 is wherein removed all basically bacterium living beings retes with the irrigation of described distribution from target site.
21. method according to claim 14 also comprises:
The working end of endoscope is sent near target site;
With the described target site of described endoscopic imaging; And
Locate described nozzle according to imaging with respect to described target site.
22. method according to claim 14 also comprises: by described irrigating catheter described target site is applied medicine, this medicine is suitable for disturbing the growth of bacterial biof iotalm.
23. method according to claim 22, wherein said medicine is selected from: surfactant, gel, antibacterial, steroid, growth hormone and combination thereof.
24. method according to claim 14, wherein said irrigant stream is conducted through described nozzle with the flow velocity of about 2ml/ second to about 12ml/ second.
25. method according to claim 14, wherein said target site is at the hole intracavity.
26. method according to claim 14, wherein said target site comprises the Ciliated epithelium.
27. method according to claim 14, wherein this method is used for the treatment of chronic sinusitis.
CN200880013653.6A 2007-04-09 2008-04-01 Surgical instrument, system, and method for biofilm removal Active CN101677749B (en)

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US9326665B2 (en) 2016-05-03
CA2682893C (en) 2017-09-26
EP2142069A4 (en) 2010-08-11
KR20100016312A (en) 2010-02-12
US20080249483A1 (en) 2008-10-09
WO2008124376A1 (en) 2008-10-16
EP2142069A1 (en) 2010-01-13
CA2682893A1 (en) 2008-10-16
CN101677749B (en) 2014-08-13
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AU2008237473B2 (en) 2013-06-20
EP2142069B1 (en) 2013-09-18

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